Advice You - Business

There are several factors that you should take into account when determining what forms of insurance coverage you want: how large or small your small busine

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ss is, how it's organized (partnership, sole proprietorship, corporation, LLC), the number of employees, how you get paid (commissions, salary, fees), wheth

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

er your small business is service or product oriented, your exposure to liability and location.

Things to ponder:

Heaven forbid, but do you have more than

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

enough insurance to protect your spouse and children? If you have a small service business, your small business is worth Zero when you die. For example, the

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

spouse of a deceased doctor or lawyer can only sell the tools of the trade, not the clients (the true bread and butter of any small service business). If y

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

u can predict when you might die, you could sell it ahead of time. But that's not very likely, so you and every small service business owner should make sur

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

e that you protect your family with at least seven times your gross income. So, if you make $100,000 per year then you should have over $700,000 in insuranc

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

e.

If your goal is to have a member of your family take over your small business at your demise, are they capable (and licensed) to do so?

What happens if

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

you get ill or suffer an injury and can no longer run your small business? Do you have disability insurance? Disability insurance will generally pay about 6

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

0% of your income for a stated period of time. The benefit may be taxable or non-taxable (depending on whether or not you deducted the premium as a business

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

expense.)

Even more important is your answer to this question: Do you have "business overhead insurance"? Who will cover the costs of running your small bu

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

siness (utilities, insurance, salaries) while you're out of commission? Unless it is an add-on, your small business overhead expenses will not be covered by

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

your disability insurance.

Got business partners? Do you have a buy/sell agreement? Well, if you or your partner should suddenly die, your interest in the

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

business will be protected. Here's a great example of this: your partner dies and his wife wants to claim her share of the business. What if your partner's

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

relatives have no idea how to operate the business? Would they be asset or a liability? Well, if you have this type of insurance coverage, you could avoid a

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

l of this interference by outside parties by simply buying out your partner's share of the business.

What about "disability buy-out coverage"? Do you have

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

it? If your partner becomes severely disabled, what would you do? Would you simply keep paying him or her even though you are doing all of the work... possi

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

bly for months or even years to come? Well, when you have "disability buy-out coverage", you would never have to wory about this situation because after a p

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

riod of time, your disabled partner would be forced to sell his share of the business to you.

Of course, many of these situations may not occur, but it's y

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

our small business. Now, all you have to do is speak to a professional to determine what forms of insurance coverage you want to protect your small business

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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